Kornimate/medical-research-clean huggingface dataset:
protocol of management of major pediatric burn in intensive care unit

Conditions: Burns

Summary: decrease mortality and morbidity in major pediatric burns

the goals of initial patient management include preservation of overall homeostasis while appreciating the physiologic challenges that the burn injury poses to the body. major burn injury not only results in local damage from the inciting injury, but in many cases results in multisystem injury. initial efforts are focused on resuscitation, maintaining hemodynamic stability, and airway management. intermediate efforts are focused on managing the multi-organ failure that results from systemic inflammatory mediators that result in diffuse capillary leak and surgical therapy. finally, efforts shift to issues with chronic wound healing, pain management, restoration of functional capabilities, and rehabilitation.. burn injury in children continues to be a major epidemiologic problem around the globe. nearly a fourth of all burn injuries occur in children under the age of 16, of whom the majority are under the age of five this provides a team of pediatricians, surgeons, anesthesiologists, intensivists, nurses, respiratory therapists, and other healthcare providers with a unique opportunity to make a multidisciplinary collaborative effort.

Eligibility criteria:
inclusion criteria: * age below 18 year * children with burn between 20% to 50% of total body surface area * recent burn within 48 hour exclusion criteria: * old burn over 48 hour after injury -burnt surface area less than 20% of total body surface area - - * burnt surface area more than 50% of total body surface area * old age over 18 year
call- associated acute fatigue in surgical residency

Conditions: Sleep Deprivation

Summary: the study aimed to evaluate the effects of 24-hour-call-associated acute partial sleep deprivation on surgical residents' technical and cognitive performance in a virtual reality (vr) setting. physiological parameters were used to quantify fatigue in respect to hours of sleep and subjective degrees of sleepiness. technical performance and cognitive skills were assessed through low- and high fidelity tasks usig the vr- simulator lapsim. objective alertness was measured by the standardized d2-paper-pencil-test. cited assessments were performed on three consecutive mornings- pre- and post-call as after 24 hours resting.

summary background data: the effect of acute partial sleep deprivation on surgical proficiency is still controversially discussed. the present study is the first to measure objective physiological parameters of fatigue in respect to subjective perceptions of sleepiness in vr- research of surgical performance. methods: 38 surgeons were explored on three consecutive mornings: prior to a 24-hour- call, post-call and after 24 hours resting. hours of sleep were recorded. subjective alertness was assessed using the standardized stanford-sleepiness-scale (sss). saliva cortisol concentrations and pupillary activity were measured by elisa and pupillography. the vr-simulator lapsim® was used to assess technical skills through defined low- fidelity vr-tasks "cutting", "clip applying" and cognitive skills through defined high-fidelity vr-tasks "intracorporal suturing", "vr-cholecystectomy". objective alertness was measured by the standardized d2-paper-pencil-test.

Eligibility criteria:
inclusion criteria: * surgical interns, junior- or senior residents * successful completion of a minimum of 10 basic vr- tasks with the vr- simulator lapsim: "camera navigation", "coordination", "clip applying", "cutting", and "diathermy cutting" and a minimum of 5 sessions of advanced vr- tasks: "fine dissection", "intracorporal suturing" and "vr- cholecystectomy" * voluntary participation * written informed consent exclusion criteria: * lack of required vr- training * lack of informed consent

Keywords: sleep-deprivation virtual reality residency performance
prognostic and predictive markers of treatment response in patients with pac.

Conditions: Pancreatic Adenocarcinoma

Summary: the objective of this study is to identify prognosis and predictive markers of response to treatments (surgery, chemotherapy,...) in patients with pancreatic adenocarcinoma. the effectiveness and tolerance of these treatments in current practice is also evaluated.

the modest efficacy of current therapies for pancreatic cancer calls for the development of prognostic factors to guide patient selection and clinical decision-making based on tumor aggressiveness and risk of death. the aim of this study is to identify prognostic and predictive factors of response to treatments administered in pancreatic adenocarcinoma, based on a multicenter cohort established on a population derived from current clinical practice. by accurately stratifying patients according to their estimated survival, prognostic tools could aid therapeutic decisions and optimize patient selection in future clinical trials.

Eligibility criteria:
inclusion criteria: * patient with histologically confirmed pancreatic adenocarcinoma. * disease at a resectable, borderline, locally advanced, initially metastatic, or recurrent stage after surgery * diagnosis between january 1, 2003, and december 31, 2030. * first-line treatment with chemotherapy and/or radiotherapy and/or clinical trials. * age ≥ 18 years. * written informed consent exclusion criteria: * patient under guardianship, curatorship, or judicial protection. * pregnant or breastfeeding women. * any medical, psychological, or social situation that could prevent compliance with the protocol as assessed by the investigator. * refusal to participate in the study
tuberculosis (tb) screening for the diagnosis of latent tb in immunocompromised populations

Conditions: Tuberculosis

Summary: the tuberculin skin test (tst) has been the gold standard for diagnosing latent tuberculosis for almost 100 years. while this test performs reasonably well in healthy, non-bacille calmette-guerin (bcg) vaccinated populations, it is believed to perform less well in patients who do not have intact cellular immune systems (immunocompromised). the investigators hypothesize that a new test, the t-spot tb elispot test will provide a more accurate measurement of latent infection in immunocompromised people. this study will compare the tst to the t-spot tb elispot test, and to the results of an expert physician diagnostic panel.

main study question: we propose to investigate the correlation between the traditional tst-based method of screening for latent tuberculosis infection in specific immunocompromised populations as recommended by canadian and american standards: the t-spot tb elispot test: and an expert tuberculosis physician panel incorporating the mantoux test, a risk factor survey, and a chest radiograph. secondary study question: in a subset of patients who have tested positive on both the mantoux and t-spot elispot tests prior to undergoing additional immune suppression i.e., patients pre-bone marrow transplant and rheumatology patients pre-receipt of anti-tnf alpha therapy or high dose corticosteroids, we propose to repeat the t-spot elispot and mantoux after immune suppression to assess the development of cutaneous anergy.

Eligibility criteria:
inclusion criteria: inclusion criteria for the study are broad. * participants can be enrolled regardless of race, gender, risk of exposure to tb, metabolic disorders or coinfection with non-tb agents. * only participants who have provided written informed consent will be included. * patients belonging to the four following groups will be considered eligible for tuberculosis screening and inclusion in the t-spot elispot study: * patients with end stage renal disease receiving hemodialysis or peritoneal dialysis; * recipients of solid organ transplants; * recipients of, or candidates for, an allogeneic stem cell transplant for hematologic malignancies; * patients with rheumatologic diseases (e.g., systemic lupus erythematosus \[sle\], rheumatoid arthritis, psoriasis) who are receiving, or about to receive, immunosuppressive therapy, including corticosteroids and anti-tnf alpha inhibitors. exclusion criteria: * individuals who have not signed an informed consent * hemophiliacs or individuals who, on the advice of the enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration

Keywords: tuberculosis tuberculin test immunologic tests latent tuberculosis end stage renal disease solid organ transplantation bone marrow transplantation rheumatologic disease
physical activity, functional fitness and quality of life after coronary artery bypass grafting

Conditions: Coronary Artery Bypass Graft

Summary: the main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (qol) among different physical activity levels in post-coronary artery bypass graft (cabg) patients; (2) to analyze the relationships between physical activity and physical fitness and qol in this population. the investigators predict physical activity and physical fitness remain limited in patients after cabg, and patients with higher physical activity levels will have higher qol and physical fitness.

heart diseases continue as the top 3 causes of death in taiwan in recent ten years. coronary artery disease (cad) is the most prevalent fatal heart disease. coronary artery bypass graft surgery (cabg) is now one of the most common procedures to treat cad. it was reported that cabg intervention could prolong the life. however, outcomes of cabg have historically been measured in terms of mortality and recurrence of symptoms or complications.there is ample evidence to demonstrate the effect and benefit of cardiac rehabilitation in qol and function activity in patients post cabg. however, the participation rate of postoperative cardiac rehabilitation is low, especially in women.little research has been done to examine the physical activity, physical performance, and qol in this population outside the cardiac rehabilitation setting.

Eligibility criteria:
inclusion criteria: * patients undergoing cabg without valve surgery exclusion criteria: 1. systemic disease, such as liver, renal disease, 2. amputation, 3. cerebrovascular disease or any others disease with limbs dysfunction, 4. lung deficit, 5. cancer, 6. cognitive disorders.

Keywords: physical activity functional fitness quality of life
the necessity of preoperative bowel preparation

Conditions: Pain, Postoperative; Analgesia

Summary: hemorrhoidectomy is an common treatment for high-grade hemorrhoids. the necessity of preoperative bowel preparation (pbp) in hemorrhoidectomy is inconclusive. this study aims to evaluate the benefit and safety of pbp in hemorrhoidectomy.

hemorrhoidectomy is an effective treatment for high-grade hemorrhoids and is recommended in patients with grade iii-iv hemorrhoids. common hemorrhoidectomy approaches include stapled hemorrhoidopexy and conventional procedures, such as ferguson hemorrhoidectomy and milligan-morgan hemorrhoidectomy. conventional techniques produce a lower recurrence rate, whereas stapled hemorrhoidopexy is associated with fewer postoperative complications and shorter recovery time. common complications after hemorrhoidectomy include urinary retention, pain, and delayed hemorrhage. surgical site infection is a rare complication after hemorrhoid excision. traditional opinions held that preoperative bowel preparation (pbp) reduces fecal mass and bacterial count in the bowel lumen, minimizing the risk of infective and anastomotic complications. however, a study that evaluated intramucosal bacterial count demonstrated that pbp does not reduce the colon bacterial count. a randomized control trial (rct) evaluating the effect of pbp before colorectal surgery suggested that the procedure can be omitted. however, another rct with 79 participants revealed that bowel preparation before anorectal surgery can result in less pain during the first postoperative defecation. a meta-analysis with 36 studies concluded that pbp before elective colorectal surgery does not affect the postoperative complication rate. on the contrary, the necessity of pbp before anorectal surgeries remains unreported. the choice of whether pbp has to be performed is often the surgeon's preference. it may be challenging for physicians to determine the appropriate decision of pbp before hemorrhoidectomy to reduce postoperative complications while minimizing patient discomfort.

Eligibility criteria:
inclusion criteria: * patients underwent hemorrhoidectomy exclusion criteria: * patients who had received emergent or other anorectal surgery, such as fistulectomy, were excluded.
quantitive lge mass in prediction of scd in nicm patients with severe cardiac dysfunction

Conditions: Cardiomyopathy

Summary: the purpose of this study is to establish a quantitative lge mass based scoring system (including lge mass on cardiac magnetic resonance , clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated cardiomyopathy patients with reduced left ventricular ejection fraction

this is a single-centered, prospective, observational study. the study design included two phases. in phase i, the investigators enrolled a set of consecutive patients with non-ischemic cardiomyopathy who performed contrast-enhanced cardiac magnetic resonance at baseline and had severe cardiac dysfunction (defined as cardiac magnetic resonance lvef equal or less than 35% ) in fuwai hospital from 2010 to 2013. the investigators collect patients' clinical baseline data and cardiac magnetic resonance specific data(late gadolinium enhancement mass). all patients were followed up every six month by phone or clinical visits. the primary endpoint was composite of sudden cardiac death(scd), ventricular arrhythmias(vas) and scd/vas related implantable cardioverter defibrillator or cardiac resynchronization therapy-cardioverter defibrillator(icd/crtd) shock. the investigators plan to establish a quantitative lge mass based model (including lge mass on cardiac magnetic resonance, clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death by analysing the phase i data(1-year model and 3-year model). in phase ii,the investigators will enroll another group of non-ischemic cardiomyopathy(nicm) patients from 2014 to 2015 to testify the risk prediction model(1-year model) the investigators have constructed in phase i. the investigators aim to find the real high risk nicm patients that may suffer from scd or vas in those with severe cardiac dysfunction.

Eligibility criteria:
inclusion criteria: * non-ischemic cardiomyopathy patients receiving optimal medical treatment for 3 months; age range from 10 years to 65 years old； baseline cardiac magnetic resonance lvef≤35% exclusion criteria: * known associated obstructive coronary heart disease（including history of myocardial infarction or acute coronary event）； valvular heart disease； malignant carcinoma ； hypertensive heart disease； severe liver or kidney dysfunction ； plan to receiving heart transplantation ； patients refuse to or cannot receive cardiac magnetic resonance ； patients refuse to be followed up ；

Keywords: sudden cardiac death ventricular arrhythmias cardiopathy late gadolinium enhancement
study of intravenously administered sns-032 in patients with advanced b-lymphoid malignancies

Conditions: B-lymphoid Malignancies; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Multiple Myeloma

Summary: the purpose of this study is to assess the safety and tolerability of escalating doses of sns-032, given in 3 weekly administrations per cycle and to identify a recommended phase 2 dose.

other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.

Eligibility criteria:
inclusion criteria: * cytologically or histologically confirmed chronic lymphocytic leukemia (cll), mantle cell lymphoma (mcl), or multiple myeloma (mm). * evidence of relapsed disease * measurable disease * eastern cooperative oncology group (ecog) performance status score of 0 or 1 exclusion criteria: * prior treatment with sns-032 injection (previously known as bms-387032) * pregnant or breastfeeding * unwilling to use an approved, effective means of contraception according to the study site's standards * use of therapeutic anticoagulation agents * prior allogeneic bone marrow transplantation * prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose. * prior pelvic radiation therapy or radiation to \> 25% of bone marrow reserve * any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures please note: there are additional inclusion/exclusion criteria for this study. please contact the study center for additional information and to determine if the patient meets all study criteria.

Keywords: leukemia lymphoma myeloma non-hodgkin's cll mcl mm phase 1 hematological malignancy
intestinal microbiome post-azythromycin/albendazole treatment

Conditions: Helminth Infection

Summary: molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond targeted pcr testing to next generation sequencing techniques. in addition, the current state of monitoring for soil-transmitted helminth infections is moving increasingly from microscopic techniques to molecular techniques. the targeted pcr test for soil transmitted helminth diagnosis has been validated on stool samples, but not rectal swabs. bulk stool samples are logistically challenging and time-intensive to collect, thus participation is often far from optimal. rectal swabs are more efficient and may result in higher participation. in this study, children will be randomized to either albendazole, azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be collected. the investigators will compare the pcr test for soil transmitted helminth infections using both the rectal swabs and the bulk stool samples. in addition, the investigators will analyze the gut microbiome of the children using next generation sequencing techniques to gain insight into effects of mass drug administration.


Eligibility criteria:
inclusion criteria: * all children 0 to 5 (up to 6th birthday) exclusion criteria: * individuals with a macrolide allergy * refusal of parent/guardian

Keywords: intestinal microbiome soil-transmitted helminths mass drug administration
effect of liraglutide on glucagon secretion in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to examine the effect of nnc 90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.


Eligibility criteria:
age: minimum 30, maximum 75 years
metabolic and immunological phenotyping in patients with cancer

Conditions: Cancer; Non-Hematologic Malignancy

Summary: an observational study to investigate cachexia in participants with non-haematological cancer.

a single-centre, non-randomised, observational study. this study will investigate the systemic metabolic and immunological changes that occur in cachexia. the aim is to better understand the mechanism(s) underlying weight loss in people with non-haematological cancer. this will help to facilitate future research to generate treatments to reverse weight loss and improve outcomes.

Eligibility criteria:
inclusion criteria: * have given written informed consent to participate * be aged 18 years or over at the time of signing the informed consent form * have a histological or cytological diagnosis of a non-haematological cancer * are willing and able to comply with study procedures and visits exclusion criteria: * active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics * current treatment with chemotherapy, oral steroids or other immunosuppressive drugs (within 7 days of baseline investigations or during the study phase) * significant acute, chronic or psychiatric condition or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the study. * intolerance to dairy products * women, who are pregnant, plan to become pregnant or are lactating

Keywords: cancer non-haematological
monitoring of the safety and the performance of the endoscopic cap electrode (ece50)

Conditions: Vocal Fold Paresis; Laryngeal Dystonia

Summary: the objective of this registry is to confirm the safety and the performance of the ece50 in medical routine by collecting data.

the endoscopic cap electrode (ece50) has been designed for the delivery of electrostimulation to selected laryngeal muscles. the primary objective of this registry is to retrieve real-life data on the safety and performance of the endoscopic cap in medical routine. subject's participation will last a maximum of 2 hours. upon successful conclusion of the screening session starts the testing session of the ece50. the ece50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region. the stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure. being a registry a collection of records generated within routine medical procedures with a medical device approved for the eu market, it does not pose additional risks for the patients participating in it.

Eligibility criteria:
inclusion criteria: * legal adults (i.e., as a general rule patients ≥ 18 years old) * legal adults requiring a diagnosis for a disorder that could be traced back to uni- or bilateral dysfunction of one or more laryngeal muscle(s) of the posterior cricoid region * signed and dated informed consent before the start of any registry-specific procedure for all the recruited subjects exclusion criteria: * lack of compliance with any inclusion criteria * use of an active medical implant * known allergies or intolerance to the material used for this registry * parallel participation in a device/drug registry in the period of data collection, which could confound the results of the registry * anything that, in the opinion of the registry responsible, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this registry